Our technology has the unique ability to detect and perform the genotyping of the 14 most frequent high- risk (hrHPV) variants without any DNA extraction step.
This unprecedented technology based on SagittaTM platform reduces the complexity and cost of HPV testing and offers new pathways in diagnosis and treatment.
With this new platform, we can screen for the presence of HPV and diagnose hrHPV on a scale never thought possible.
Available as CE-IVD or RUO version.
Our first application with the Sagitta platform is with Human Papilloma Virus (HPV) which is known to cause cervical and other cancers types. With HPV Selfy testing can be performed by self-sampling patients or clinicians using a simple swab to detect and diagnose HPV infection. Our technology has the unique ability to detect and genotype all 14 high-risk (hrHPV) variants without DNA extraction. This unprecedented technology reduces the complexity and cost of HPV testing and offers new pathways in diagnosis and treatment. With this new platform, we can screen for the presence of HPV and diagnose hrHPV on a scale never thought possible.
The HPV Selfy product is a unique approach allowing healthcare consumers to simple self-sample and give their clinicians the diagnostic power of genotyping hrHPV and the technology does not require DNA extraction allowing the lab to reduce complexity and cost resulting in a faster more efficient process.
HPV Selfy is targeting the 8 million HPV women globally are at risk of developing cervical cancer caused by Human Papillomavirus (HPV). The HPV testing market is expected to grow at a rate of 10% per year over the next 5 years.
HPV Selfy can screen for the presence of HPV and diagnose (high-risk) hrHPV at lower cost and greater scale than previously possible.
a. Source: QYR Pharma & Healthcare Research Center, Mar 2017
Cervical cancer is the fourth most frequent cancer in women with more than 500,000 cases worldwide and is mostly caused by a persistent infection of hrHPV genotypes. Just under $300 million is spent annually on HPV testing in the USA, with Europe as the next largest market at just under $200 million annually. Currently the CDC and World Health Organization recommend detecting cervical cell dysplasia through a Pap test with a co-test for HPV.
HPV is most closely associated with cervical cancer and categorized as a women’s health issue. In reality, HPV is a human issue in that men carry the virus and transmit the virus to their partners. Men are also susceptible to oral/pharyngeal and anogenital related cancers. There are no current commercial screening methods for men. Yet according to the CDC, all rates of HPV including; oral, anal/rectal and genital, are higher in men than in women.
HPV vaccines that prevent HPV 16 and 18 ( last vaccine prevent 7 out of 14 high risk HPV, old and first vaccine prevented only 16 and 18 genotypes = genotyping is important for controlling rare and new HPV genotypes diffusion) infections are now available and have the potential to reduce the incidence of cervical and other anogenital cancers. These vaccines are recommended for children under age 14, however, patient adoption has been lower then expected. The HPV vaccine will reduce the rates of infection in youths but not abate or reduce the need for screening in men and women who will continue to become infected with HPV and be carriers of the virus unless diagnosed. Although most variants and incidences of HPV clear themselves, to win the war on hrHPV variants and reduce HPV related cancers, routine screening and treatment must occur. This is a global public health issue.
NanOracle is a simple and portable device which can be managed in ambulatory setting or at home. NanOracle is a common and simple reader that can be fluorescence based or electrochemical depending on the used Nanohybrid platform.
This strip/cartridge system is really user friendly and capable to give a simple readout within few minutes. Depending on the loaded strips is possible to use NanOracle for both diagnostic and theranostic purposes.